EP2974673B1 - Implantierbare biomedizinische vorrichtungen auf bioresorbierbaren substraten - Google Patents

Implantierbare biomedizinische vorrichtungen auf bioresorbierbaren substraten Download PDF

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EP2974673B1
EP2974673B1 EP15179455.9A EP15179455A EP2974673B1 EP 2974673 B1 EP2974673 B1 EP 2974673B1 EP 15179455 A EP15179455 A EP 15179455A EP 2974673 B1 EP2974673 B1 EP 2974673B1
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European Patent Office
Prior art keywords
barrier layer
substrate
silk
bioresorbable
optionally
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English (en)
French (fr)
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EP2974673A1 (de
Inventor
John A. Rogers
Dae-Hyeong Kim
Fiorenzo G. Omenetto
David Kaplan
Brian Litt
Jonathan Viventi
Yonggang Huang
James Amsden
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Northwestern University
University of Pennsylvania Penn
Tufts University
University of Illinois at Urbana Champaign
University of Illinois System
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Northwestern University
University of Pennsylvania Penn
Tufts University
University of Illinois at Urbana Champaign
University of Illinois System
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/043—Proteins; Polypeptides; Degradation products thereof
    • A61L31/047—Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y15/00—Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0285—Nanoscale sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • H—ELECTRICITY
    • H05—ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05K—PRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K1/00—Printed circuits
    • H05K1/02—Details
    • H05K1/0277—Bendability or stretchability details
    • H05K1/0283—Stretchable printed circuits
    • H—ELECTRICITY
    • H05—ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05K—PRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K3/00—Apparatus or processes for manufacturing printed circuits
    • H05K3/10—Apparatus or processes for manufacturing printed circuits in which conductive material is applied to the insulating support in such a manner as to form the desired conductive pattern
    • H05K3/20—Apparatus or processes for manufacturing printed circuits in which conductive material is applied to the insulating support in such a manner as to form the desired conductive pattern by affixing prefabricated conductor pattern

Definitions

  • amorphous silicon, organic or hybrid organic-inorganic semiconductors which exhibit electronic properties, such as field effect mobilities, on/off ratios, etc., significantly inferior to corresponding single crystalline silicon-based devices. While such amorphous silicon and organic-based materials may be electronically inferior to singe crystalline silicon, they do have certain properties useful for biomedical applications, such as flexibility, chemically biocompatibility and, in some cases, biodegradability.
  • devices of the invention are useful for in vivo sensing of a parameter associated with a target tissue and/or biological environment, such as a chemical composition (e.g., pH, ionic strength, presence or concentration of a biomarker, protein, carbohydrate, etc.), an electrochemical parameter (e.g., current or voltage), temperature, and/or an optical parameter (e.g., absorption, scattering, etc.).
  • a chemical composition e.g., pH, ionic strength, presence or concentration of a biomarker, protein, carbohydrate, etc.
  • an electrochemical parameter e.g., current or voltage
  • temperature e.g., temperature
  • an optical parameter e.g., absorption, scattering, etc.
  • devices of the invention are useful for in vivo actuation of a target tissue in a biological environment such as electrochemical actuation, drug delivery, optical actuation etc.
  • a thin bioresorbable substrate e.g., thickness less than or equal to 100 microns, optionally less than or equal to 10 microns and optionally less than or equal to 1 micron
  • the bioresorbable substrate has a thickness selected over the range of 100 nanometers and 10000 ⁇ m, optionally for some applications selected over the range of 1 ⁇ m and 1000 ⁇ m, and optionally for some embodiments selected over the range of 1 ⁇ m and 10 ⁇ m.
  • the invention includes implantable devices having a bioresorbable substrate with a degree of crystallinity less than or equal to 55%, and optionally a degree of crystallinity less than or equal to 30% and optionally a degree of crystallinity less than or equal to 20%, and optionally a degree of crystallinity less than or equal to 5%.
  • the invention includes implantable devices having a bioresorbable substrate with a degree of crystallinity selected over the range of 0 to 55%, and optionally for some embodiments a degree of crystallinity selected over the range of 1 to 30%, and optionally for some embodiments a degree of crystallinity selected over the range of 5 to 20%.
  • the inorganic semiconductor components of the electronic device have a thickness less than or equal to 100 microns, and for some applications have a thickness less than or equal to 10 microns, and for some applications have a thickness less than or equal to 1 micron, and for some applications have a thickness less than or equal to 500 nanometers, and for some applications have a thickness less than or equal to 100 nanometers.
  • the electrodes of the electrode array are metal films, for example thin (e.g., thickness ⁇ 100 microns) metal films.
  • Use of thin electrodes e.g., thickness less than or equal to 100 microns, optionally less than or equal to 10 microns and optionally less than or equal to 1 micron
  • the electrodes comprise a biocompatible metal, such as titanium, gold, silver, platinum, and any combination of these.
  • the foot print area of the device is an area corresponding to the perimeter of the device that establishes the interface with a target tissue
  • the mesh structure of the barrier layer occupies a portion, but not all of the, foot print area.
  • Mesh structures in some embodiments, occupy 75% or less than the foot print area and/or tissue interface area of the device, and optionally 50 % or less than the foot print area and/or tissue interface area; and optionally 25 % or less than the foot print area and/or tissue interface area of the device.
  • the barrier layer has a mesh structure that is a lattice structure, a perforated structure or a tentacle structure.
  • composition and physical dimensions of the barrier layer are also parameters useful for providing an implantable device useful for establishing conformal contact with a target tissue.
  • Use of a thin barrier layer e.g., thickness less than or equal to 100 microns, optionally less than or equal to 10 microns, and optionally less than or equal to 1 micron
  • the barrier layer comprises a polymer material, such as an elastomer, a thermoset, a thermoplastic, or a composite polymer material.
  • the barrier layer is polyimide.
  • the electronic device and barrier layer have a mesh structure, which is formed by removing at least a portion of one or more supporting or encapsulating layers located proximate to an electronic device component (e.g., inorganic semiconductor element, electrode, etc.) to provide a perforated structure, having one or more holes, or a tentacle structure, where semiconductor components are physically connected at a proximal end but physically separated at a distal end.
  • an electronic device component e.g., inorganic semiconductor element, electrode, etc.
  • the inorganic semiconductor components or electrodes of the electrode array have thicknesses less than or equal to 100 microns, optionally less than or equal to 10 microns, and optionally less than or equal to 1 microns.
  • the method further comprises providing an adhesive layer on the receiving surface of the bioresorbable substrate prior to the step of assembling the plurality of inorganic semiconductor components or electrodes of an electrode array on the receiving surface of the bioresorbable substrate by transfer printing.
  • “Functional layer” refers to a layer that imparts some functionality to the device.
  • the functional layer may contain semiconductor components.
  • the functional layer may comprise multiple layers, such as multiple semiconductor layers separated by support layers.
  • the functional layer may comprise a plurality of patterned elements, such as interconnects running between electrodes or islands.
  • the functional layer may be heterogeneous or may have one or more properties that are inhomogeneous.
  • “Inhomogeneous property” refers to a physical parameter that can spatially vary, thereby effecting the position of the neutral mechanical plane within a multilayer device.
  • semiconductor refers to any material that is an insulator at a very low temperature, but which has an appreciable electrical conductivity at a temperature of about 300 Kelvin. In the present description, use of the term semiconductor is intended to be consistent with use of this term in the art of microelectronics and electronic devices.
  • NMP Neuronal mechanical plane
  • the NMP is less susceptible to bending stress than other planes of the device that lie at more extreme positions along the vertical, h, axis of the device and/or within more bendable layers of the device.
  • the position of the NMP is determined by both the thickness of the device and the materials forming the layer(s) of the device.
  • a barrier layer(s), and optionally a sacrificial layer on a substrate may be etched to produce a "mesh structure", where at least a portion of the barrier layer(s), and optionally the sacrificial layer on a substrate , is removed. For example a portion of the barrier layer(s) disposed approximately 10 nanometers or more from an inorganic semiconductor component or additional component is removed. Removal of at least a portion of the barrier layer(s), and optionally the sacrificial layer on the substrate, may produce (i) one or more holes within the barrier layer(s) and/or (ii) electrical components, which are physically joined by a barrier layer(s) at a proximal end and physically separated at a distal end.
  • a mesh structure may be disposed upon a contiguous bioresorbable substrate, which provides structural support for the device during deployment into a biological environment.
  • Bioinert refers to a material that does not elicit an immune response from a human or animal when it is disposed within an in-vivo biological environment.
  • a biological marker indicative of an immune response remains substantially constant (plus or minus 5% of a baseline value) when a bioinert material is implanted into a human or animal.
  • Polymer refers to a macromolecule composed of repeating structural units connected by covalent chemical bonds or the polymerization product of one or more monomers, often characterized by a high molecular weight.
  • the term polymer includes homopolymers, or polymers consisting essentially of a single repeating monomer subunit.
  • polymer also includes copolymers, or polymers consisting essentially of two or more monomer subunits, such as random, block, alternating, segmented, grafted, tapered and other copolymers.
  • Useful polymers include organic polymers or inorganic polymers that may be in amorphous, semi-amorphous, crystalline or partially crystalline states. Crosslinked polymers having linked monomer chains are particularly useful for some applications.
  • Electrodes to each electrode were protected by a thin ( ⁇ 1.2 ⁇ m) overcoat of PI to prevent contact with the tissue. Details of the fabrication steps appear in the methods section.
  • the electrode arrays were implanted by placing them on the brain and then flushing with saline to dissolve the silk, thereby inducing spontaneous, conformal wrapping of the device, as illustrated schematically for the mesh design in Fig. 13c .
  • the mesh design involves membrane strains that are smaller, by roughly a factor of w / r , compared to sheets with similar thickness. For the experimental mesh systems, this ratio is on the order of 1/4.
  • the normal (peeling) interfacial stresses for the mesh is only 1/4 of that for the sheet (right frame of Fig. 21e and Fig. 24b ), leading to improved adhesion and reduced forces applied to the substrate. See below for details.
  • ⁇ normal sheet E ⁇ PI 1 + v PI h ⁇ h m + E ⁇ Au 1 + v Au h m R 1 ⁇ R r + w sin r + w R .

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  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Claims (20)

  1. Implantierbare biomedizinische Vorrichtung zum Betätigen eines Zielgewebes oder zum Erfassen eines Parameters, welcher mit dem Zielgewebe in einer biologischen Umgebung verbunden ist, wobei die Vorrichtung umfasst:
    eine elektronische Vorrichtung umfassend eine Vielzahl an anorganischen Komponenten, wobei zumindest eine der anorganischen Komponenten zumindest eine physische Abmessung kleiner als oder gleich 100 Mikrometer aufweist;
    eine Sperrschicht, welche zumindest einen Teil der anorganischen Komponenten ummantelt; und
    eine Komponente zum Analysieren von Daten, welche von der elektronischen Vorrichtung erhalten wurden, oder zum Abgeben von elektromagnetischer Strahlung an die elektronische Vorrichtung;
    wobei die elektronische Vorrichtung und die Sperrschicht eine Nettobiegesteifigkeit der implantierbaren biomedizinischen Vorrichtung von weniger als 1 x 109 GPa µm4 bereitstellen.
  2. Vorrichtung nach Anspruch 1, wobei die anorganischen Komponenten aus der Gruppe bestehend aus anorganischen Halbleiterkomponenten, individuell adressierbaren Metallelektroden und Kombinationen davon ausgewählt sind.
  3. Vorrichtung nach Anspruch 2, wobei jede der Metallelektroden eine Dicke weniger als oder gleich 10 Mikrometer aufweist.
  4. Vorrichtung nach Anspruch 2, wobei die Metallelektroden ein bioinertes Metall oder ein biokompatibles Metall umfassen.
  5. Vorrichtung nach Anspruch 1, weiter umfassend eine biokompatible Schicht, welche die Vielzahl an anorganischen Komponenten trägt.
  6. Vorrichtung nach Anspruch 5, wobei die biokompatible Schicht eine Dicke ausgewählt aus dem Bereich von 1 µm bis 25 µm aufweist.
  7. Vorrichtung nach Anspruch 1, wobei zumindest eine der anorganischen Komponenten eine flexible Halbleiterstruktur oder eine dehnbare Halbleiterstruktur ist.
  8. Vorrichtung nach Anspruch 1, wobei zumindest eine der anorganischen Komponenten ein Nanoband, eine Nanomembran, ein Nanodraht, ein Transistorkanal, eine Diode, eine p-n-Verbindung, eine Photodiode, eine lichtemittierende Diode, ein Laser oder eine Kombination von diesen ist.
  9. Vorrichtung nach Anspruch 1, wobei zumindest eine der anorganischen Komponenten der elektronischen Vorrichtung eine Dicke von weniger als oder gleich 10 Mikrometer aufweist.
  10. Vorrichtung nach Anspruch 1, wobei zumindest eine der anorganischen Komponenten der elektronischen Vorrichtung ein Elastizitätsmodul ausgewählt aus dem Bereich von 0,5 MPa bis 10 GPa aufweist.
  11. Vorrichtung nach Anspruch 1, wobei zumindest eine der anorganischen Komponenten ein einkristallines anorganisches Halbleitermaterial umfasst.
  12. Vorrichtung nach Anspruch 1, wobei zumindest eine der anorganischen Komponenten Material ausgewählt aus der Gruppe bestehend aus einkristallinem Silizium, porösem Silizium und polykristallinem Silizium umfasst.
  13. Vorrichtung nach Anspruch 1, wobei zumindest eine der anorganischen Komponenten oder der Sperrschicht ein bioresorbierbares Material oder bioinertes Material umfasst.
  14. Vorrichtung nach Anspruch 1, wobei die Sperrschicht alle der anorganischen Komponenten der elektronischen Vorrichtung ummantelt.
  15. Vorrichtung nach Anspruch 1, wobei die Sperrschicht Material ausgewählt aus einer Gruppe bestehend aus einem Polymer, einem organischen Polymer, SU-8, einem Isolator, einem Polyimid, einem Dielektrikum, einem anorganischen Dielektrikum, Si3N4 und eine Kombination von diesen umfasst.
  16. Vorrichtung nach Anspruch 1, wobei die Sperrschicht den Nettoleckagestrom von der elektronischen Vorrichtung auf 10 µA/µm2 oder weniger begrenzt.
  17. Vorrichtung nach Anspruch 1, wobei die Sperrschicht eine Dicke von weniger als oder gleich 100 µm aufweist.
  18. Vorrichtung nach Anspruch 1, wobei die Sperrschicht eine ebene Kontaktfläche zum Kontaktieren des Zielgewebes aufweist.
  19. Vorrichtung nach Anspruch 1, wobei die Sperrschicht eine nanostrukturierte oder mikrostrukturierte Kontaktoberfläche zum Kontaktieren des Zielgewebes aufweist.
  20. Vorrichtung nach Anspruch 1, wobei die Sperrschicht eine Maschenstruktur aufweist.
EP15179455.9A 2010-03-17 2010-09-28 Implantierbare biomedizinische vorrichtungen auf bioresorbierbaren substraten Active EP2974673B1 (de)

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EP2963675A1 (de) 2008-03-05 2016-01-06 The Board of Trustees of The University of Illinois Dehnbare und faltbare elektronische vorrichtungen
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CN102892356A (zh) 2013-01-23
JP5751728B2 (ja) 2015-07-22
HK1205445A1 (en) 2015-12-18
KR20130057983A (ko) 2013-06-03
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CN105496423A (zh) 2016-04-20
WO2011115643A1 (en) 2011-09-22
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JP2015164564A (ja) 2015-09-17
HK1221623A1 (zh) 2017-06-09
CN102892356B (zh) 2016-01-13
EP2547258A1 (de) 2013-01-23
US8666471B2 (en) 2014-03-04
EP2974673A1 (de) 2016-01-20
HK1181625A1 (zh) 2013-11-15
EP2547258A4 (de) 2014-06-04
US20140163390A1 (en) 2014-06-12
US20110230747A1 (en) 2011-09-22
CN104224171B (zh) 2017-06-09
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EP2547258B1 (de) 2015-08-05
CN104224171A (zh) 2014-12-24

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